Quality Management System Development

Avarent will provide an objective look at your current system and will recommend changes based on our experience within your specific industry.

We will leverage your internal knowledge of the organization and our industry wide experience to develop and redefine the current processes to ensure compliance and reduce risk while increasing the overall efficiency of the processes.

Our experience includes FDA, ISO, GAMP, HIPAA and Sarbanes-Oxley.

Validation

Avarent consultants will assess your current state of compliance and provide insight into developing a more robust validation practice at your company. We can deliver complete validation documentation or develop a process with templates ensuring that your company can continue on its own successfully. Our experiences range from developing and implementing strategies for retro-validation of ERPs to process validation of new facilities.

Manufacturing Feasibility

Avarent will determine the engineering feasibility of your scale-up requirements as well as determine the best approach for increased ROI. We can provide an outside view of plans prior to construction or develop approaches to increase efficiency in your current facilities.

Our broad based manufacturing experience includes biologic, pharmaceutical, dose delivery systems and medical device.

PDMA Compliance

Avarent will provide a top - down view of your compliance with PDMA and your sample accountability. We provide in depth views of your software as well as your processes to ensure that risk and liability is reduced to acceptable levels while efficiency is maintained.